VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

Nationwide Children's Hospital

Status: Active, not recruiting

Conditions: Procedural Anxiety; Procedural Pain

Treatments: Other: VR-PAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05645224

STUDY00002880

Details and patient eligibility

About

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

Full description

In this two-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group or control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser
• have a legal guardian present for patients less than 18 years old for the procedure (for informed consent)
• can communicate orally

Exclusion criteria

• any wounds that may interfere with study procedures
• usage of a diode laser (VR safety has not been established yet)
• vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
• history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
• minors in foster care
• unable to communicate in English
• pregnant women
• prisoners

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

VR-PAT

Experimental group

Description:

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.

Treatment:

Other: VR-PAT

Control

No Intervention group

Description:

Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.